FDA Inspection
Hanlim Pharm Co., Ltd.Hanlim Pharm Co., Ltd. – FDA Inspection, Apr 24, 2026
Record Details
This FDA Inspection record concerns Hanlim Pharm Co., Ltd., with an inspection on April 24, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 84952638-87a5-4c06-9fc9-abb504ed78d2
Inspection Facts
- Inspection number
- 1313712
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of Hanlim Pharm Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2026 | Not classified | Office of Inspections and Investigations | |
| May 31, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 19, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hanlim Pharm Co., Ltd.
- FDA Inspection 1316122 - 2026-04-10
- FDA Inspection 1171848 - 2022-05-31
- FDA Inspection 1039954 - 2018-02-06
- FDA Inspection 985577 - 2016-07-19
- FDA Inspection 879041 - 2014-04-18
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